ID

16470

Description

Study to Evaluate Efficacy of Micardis® (Telmisartan) and Valsartan in Patients With Mild-to-moderate Hypertension After Missing One Dose Using Ambulatory Blood Pressure Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT02242318

Link

https://clinicaltrials.gov/show/NCT02242318

Keywords

Versions (1)
  1. 7/17/16 7/17/16 -
Uploaded on

July 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT02242318

English

Eligibility Hypertension NCT02242318

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmhg and ≤ 109 mmhg, measured by manual cuff sphygmomanometer, at visit 2
Description

mild-to-moderate hypertension

Data type

boolean

Alias
UMLS CUI [1]
C3276943
UMLS CUI [2]
C1969581
2. 24-hour mean dbp of ≥ 85 mmhg at visit 3 as measured by abpm
Description

diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0428883
3. age 18 years or older
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
Description

ability to stop any current antihypertensive therapy without risk to the patient

Data type

boolean

Alias
UMLS CUI [1]
C0585941
5. patient's written informed consent in accordance with good clinical practice (gcp) and local legislation
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
Description

pre-menopausal women

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0279752
1. are not surgically sterile,
Description

are not surgically sterile

Data type

boolean

Alias
UMLS CUI [1]
C0021359
2. are nursing,
Description

nursing

Data type

boolean

Alias
UMLS CUI [1]
C0006147
3. are of child-bearing potential and are not practising acceptable methods of birth control, or do not plan to continue practising an acceptable method throughout the study. acceptable methods of birth control include oral, implantable or injectable contraceptives and intra uterine devices (iud)
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
2. known or suspected secondary hypertension
Description

known or suspected secondary hypertension

Data type

boolean

3. mean sitting sbp ≥180 mmhg or mean sitting dbp ≥110 mmhg during any visit of the placebo run-in period
Description

sitting systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1319893
4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Description

hepatic and/or renal dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C3279454
1. serum glutamate-pyruvate-transaminase (alanine aminotransferase) (sgpt (alt)) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) (sgot (ast)) > than 2 times the upper limit of normal range,
Description

AST and ALT level

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
2. serum creatinine > 2.3 mg/dl (or > 203 μmol/l)
Description

serum creatinine

Data type

boolean

Alias
UMLS CUI [1]
C0201976
5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
Description

renal artery stenosis, postrenal transplant or with only one kidney

Data type

boolean

Alias
UMLS CUI [1]
C0035067
UMLS CUI [2]
C0022671
UMLS CUI [3]
C0426706
6. clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
Description

sodium depletion, hypokalaemia or hyperkalaemia

Data type

boolean

Alias
UMLS CUI [1]
C0020625
UMLS CUI [2]
C0020621
UMLS CUI [3]
C0020461
7. uncorrected volume depletion
Description

uncorrected volume depletion

Data type

boolean

Alias
UMLS CUI [1]
C0546884
8. primary aldosteronism
Description

primary aldosteronism

Data type

boolean

Alias
UMLS CUI [1]
C1719312
9. hereditary fructose intolerance
Description

hereditary fructose intolerance

Data type

boolean

Alias
UMLS CUI [1]
C0016751
10. biliary obstructive disorders
Description

biliary obstructive disorders

Data type

boolean

Alias
UMLS CUI [1]
C0400979
11. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists
Description

angioedema during treatment with ace inhibitors or angiotensin II receptor antagonists

Data type

boolean

Alias
UMLS CUI [1,1]
C0570450
UMLS CUI [1,2]
C0002994
UMLS CUI [2,1]
C1319923
UMLS CUI [2,2]
C0002994
12. history of drug or alcohol dependency within six months prior to start of run-in period
Description

substance use disorder

Data type

boolean

Alias
UMLS CUI [1]
C0038586
13. concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
Description

concomitant administration of any medications known to affect blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0003364
14. any investigational therapy within one month of signing the informed consent form
Description

any investigational therapy

Data type

boolean

Alias
UMLS CUI [1]
C1548937
15. congestive heart failure (new york heart association (nyha) functional class congestive heart failure (chf iii-iv))
Description

congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
16. unstable angina within the past three months prior to start of run-in period
Description

unstable angina

Data type

boolean

Alias
UMLS CUI [1]
C0002965
17. stroke within the past six months prior to start of run-in period
Description

stroke

Data type

boolean

Alias
UMLS CUI [1]
C0038454
18. myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
Description

myocardial infarction or cardiac surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0018821
19. percutaneous transluminal coronary angioplasty (ptca) within the past three months prior to start of run-in period
Description

ptca

Data type

boolean

Alias
UMLS CUI [1]
C2936173
20. sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
Description

arrhythmias

Data type

boolean

Alias
UMLS CUI [1]
C0003811
21. hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Description

hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve

Data type

boolean

Alias
UMLS CUI [1]
C0007194
UMLS CUI [2]
C0003499
UMLS CUI [3]
C0003507
UMLS CUI [4]
C0026269
22. patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c ≥ 10%
Description

uncontrolled diabetes mellitus hba1c

Data type

boolean

Alias
UMLS CUI [1,1]
C0743131
UMLS CUI [1,2]
C0202054
23. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (am)
Description

night shift workers who routinely sleep during the daytime

Data type

boolean

Alias
UMLS CUI [1,1]
C0555008
UMLS CUI [1,2]
C4075948
24. known hypersensitivity to any component of the formulations
Description

hypersensitivity to any component of the formulations

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
25. any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
Description

clinical condition compromising study protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C2348563
26. inability to comply with the protocol
Description

inability to comply with the protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Hypertension NCT02242318

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
mild-to-moderate hypertension
Item
1. mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥ 95 mmhg and ≤ 109 mmhg, measured by manual cuff sphygmomanometer, at visit 2
boolean
C3276943 (UMLS CUI [1])
C1969581 (UMLS CUI [2])
diastolic blood pressure
Item
2. 24-hour mean dbp of ≥ 85 mmhg at visit 3 as measured by abpm
boolean
C0428883 (UMLS CUI [1])
age
Item
3. age 18 years or older
boolean
C0001779 (UMLS CUI [1])
ability to stop any current antihypertensive therapy without risk to the patient
Item
4. ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion)
boolean
C0585941 (UMLS CUI [1])
written informed consent
Item
5. patient's written informed consent in accordance with good clinical practice (gcp) and local legislation
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
pre-menopausal women
Item
1. pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who
boolean
C0043210 (UMLS CUI [1,1])
C0279752 (UMLS CUI [1,2])
are not surgically sterile
Item
1. are not surgically sterile,
boolean
C0021359 (UMLS CUI [1])
nursing
Item
2. are nursing,
boolean
C0006147 (UMLS CUI [1])
contraception
Item
3. are of child-bearing potential and are not practising acceptable methods of birth control, or do not plan to continue practising an acceptable method throughout the study. acceptable methods of birth control include oral, implantable or injectable contraceptives and intra uterine devices (iud)
boolean
C0700589 (UMLS CUI [1])
known or suspected secondary hypertension
Item
2. known or suspected secondary hypertension
boolean
sitting systolic blood pressure
Item
3. mean sitting sbp ≥180 mmhg or mean sitting dbp ≥110 mmhg during any visit of the placebo run-in period
boolean
C1319893 (UMLS CUI [1])
hepatic and/or renal dysfunction
Item
4. hepatic and/or renal dysfunction as defined by the following laboratory parameters:
boolean
C0086565 (UMLS CUI [1])
C3279454 (UMLS CUI [2])
AST and ALT level
Item
1. serum glutamate-pyruvate-transaminase (alanine aminotransferase) (sgpt (alt)) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) (sgot (ast)) > than 2 times the upper limit of normal range,
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
serum creatinine
Item
2. serum creatinine > 2.3 mg/dl (or > 203 μmol/l)
boolean
C0201976 (UMLS CUI [1])
renal artery stenosis, postrenal transplant or with only one kidney
Item
5. bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
boolean
C0035067 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
C0426706 (UMLS CUI [3])
sodium depletion, hypokalaemia or hyperkalaemia
Item
6. clinically relevant sodium depletion, hypokalaemia or hyperkalaemia
boolean
C0020625 (UMLS CUI [1])
C0020621 (UMLS CUI [2])
C0020461 (UMLS CUI [3])
uncorrected volume depletion
Item
7. uncorrected volume depletion
boolean
C0546884 (UMLS CUI [1])
primary aldosteronism
Item
8. primary aldosteronism
boolean
C1719312 (UMLS CUI [1])
hereditary fructose intolerance
Item
9. hereditary fructose intolerance
boolean
C0016751 (UMLS CUI [1])
biliary obstructive disorders
Item
10. biliary obstructive disorders
boolean
C0400979 (UMLS CUI [1])
angioedema during treatment with ace inhibitors or angiotensin II receptor antagonists
Item
11. patients who have previously experienced symptoms characteristic of angioedema during treatment with ace inhibitors or angiotensin ii receptor antagonists
boolean
C0570450 (UMLS CUI [1,1])
C0002994 (UMLS CUI [1,2])
C1319923 (UMLS CUI [2,1])
C0002994 (UMLS CUI [2,2])
substance use disorder
Item
12. history of drug or alcohol dependency within six months prior to start of run-in period
boolean
C0038586 (UMLS CUI [1])
concomitant administration of any medications known to affect blood pressure
Item
13. concomitant administration of any medications known to affect blood pressure, except medication allowed by the protocol
boolean
C0003364 (UMLS CUI [1])
any investigational therapy
Item
14. any investigational therapy within one month of signing the informed consent form
boolean
C1548937 (UMLS CUI [1])
congestive heart failure
Item
15. congestive heart failure (new york heart association (nyha) functional class congestive heart failure (chf iii-iv))
boolean
C0018802 (UMLS CUI [1])
unstable angina
Item
16. unstable angina within the past three months prior to start of run-in period
boolean
C0002965 (UMLS CUI [1])
stroke
Item
17. stroke within the past six months prior to start of run-in period
boolean
C0038454 (UMLS CUI [1])
myocardial infarction or cardiac surgery
Item
18. myocardial infarction or cardiac surgery within the past three months prior to start of run-in period
boolean
C0027051 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
ptca
Item
19. percutaneous transluminal coronary angioplasty (ptca) within the past three months prior to start of run-in period
boolean
C2936173 (UMLS CUI [1])
arrhythmias
Item
20. sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator
boolean
C0003811 (UMLS CUI [1])
hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
Item
21. hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
boolean
C0007194 (UMLS CUI [1])
C0003499 (UMLS CUI [2])
C0003507 (UMLS CUI [3])
C0026269 (UMLS CUI [4])
uncontrolled diabetes mellitus hba1c
Item
22. patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past three months as defined by an hba1c ≥ 10%
boolean
C0743131 (UMLS CUI [1,1])
C0202054 (UMLS CUI [1,2])
night shift workers who routinely sleep during the daytime
Item
23. night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (am)
boolean
C0555008 (UMLS CUI [1,1])
C4075948 (UMLS CUI [1,2])
hypersensitivity to any component of the formulations
Item
24. known hypersensitivity to any component of the formulations
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
clinical condition compromising study protocol
Item
25. any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
inability to comply with the protocol
Item
26. inability to comply with the protocol
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
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